Devices and methods for cardiac pacing and resynchronization

ABSTRACT

Devices and methods can be used for artificial cardiac pacing and/or resynchronization. For example, this document provides improved electrodes for stimulating and sensing electrical activity of the heart, and provides pacing and resynchronization systems incorporating such electrodes. While the devices and methods provided herein are described primarily in the context of pacing, it should be understood that resynchronization can additionally or alternatively be performed in an analogous manner, and that the scope of this disclosure includes such subject matter.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.62/327,862, filed Apr. 26, 2016. The disclosure of the prior applicationis considered part of and is incorporated by reference in the disclosureof this application.

BACKGROUND 1. Technical Field

This document relates to devices and methods for artificial cardiacpacing and/or resynchronization. For example, this document relates toimproved electrodes for stimulating and sensing electrical activity ofthe heart, and to pacing and resynchronization systems incorporatingsuch electrodes.

2. Background Information

A pacemaker system is a small, battery-operated device that senses whena heart is beating irregularly or too slowly. The pacemaker system canalso generate and deliver pulse signals to the heart to induce the heartto beat at the correct pace.

The primary purpose of a pacemaker is to maintain an adequate heartrate, either because the heart's natural pacemaker is not fast enough,or because there is a block in the heart's electrical conduction system.Arrhythmias are problems with the rate or rhythm of the heartbeat.During an arrhythmia, the heart can beat too fast, too slow, or with anirregular rhythm.

Most conventional pacemakers have two parts. One part is the generatorcontaining a battery and the electrical circuitry to control theheartbeat. Another part are one or more leads. Leads are wires thatconnect the heart to the generator and carry the electrical signals toand from the heart. The leads detect the heart's rhythm contractions andsend corresponding signals to the controller of the generator. Also, theleads carry the pacing pulses from the generator to the myocardium.

Modern pacemakers are externally programmable and allow a cardiologistto select the optimum pacing modes for individual patients. Some combinea pacemaker and defibrillator in a single implantable device. Othershave multiple electrodes stimulating differing positions within theheart to improve the atrioventricular synchronization of the heart.

SUMMARY

This document provides devices and methods for artificial cardiac pacingand/or resynchronization. For example, this document provides improvedelectrodes for stimulating and sensing electrical activity of the heart,and to pacing and resynchronization systems incorporating suchelectrodes.

In one aspect, a cardiac pacing device includes a first flange portion;a second flange portion; a central portion extending between andconnecting the first flange portion and the second flange portion; andone or more pacing electrodes exposed on an inward-facing surface of thefirst flange portion that faces the second flange portion.

Such a cardiac pacing device may optionally include one of more of thefollowing features. The cardiac pacing device may also include one ormore pacing electrodes exposed on an inward-facing surface of the secondflange portion that faces the first flange portion. The cardiac pacingdevice may also include one or more resynchronization coils exposed onthe inward-facing surface of the first flange portion that faces thesecond flange portion. The cardiac pacing device may also include one ormore conductive leads extending from the cardiac pacing device (the oneor more conductive leads in electrical communication with the one ormore pacing electrodes), and a pulse generator attached to the one ormore conductive leads and configured for sending electrical pulses forcardiac pacing via the one or more conductive leads to the one or morepacing electrodes. The cardiac pacing device may also include a wirelessreceiver configured for wireless communication with a controllerseparated from the cardiac pacing device. The controller may wirelesslycommunicate to the cardiac pacing device to control the cardiac pacingdevice. The cardiac pacing device may also include a controllercircuitry coupled housed in the cardiac pacing device. The cardiacpacing device may be a fully self-contained pacing device. The cardiacpacing device may also include one or more pressure sensors coupled tothe cardiac pacing device and configured for detecting a fluid pressureadjacent the cardiac pacing device. The one or more pressure sensors mayinclude a first pressure sensor coupled to the first flange portion anda second pressure sensor coupled to the second flange portion. The firstpressure sensor may be configured to detect a fluid pressure in a firstheart chamber. The second pressure sensor may be configured to detect afluid pressure in a second heart chamber that differs from the firstheart chamber. The first heart chamber and the second heart chamber maybe either both atria or both ventricles.

In another aspect, a method of treating a human heart by implanting apacing device in the heart is provided. The pacing device includes afirst flange portion; a second flange portion; a central portionextending between and connecting the first flange portion and the secondflange portion; and one or more pacing electrodes exposed on aninward-facing surface of the first flange portion that faces the secondflange portion. The first flange portion is disposed in a first heartchamber, the second flange portion is disposed in a second heart chamberthat differs from the first heart chamber, and the central portion isdisposed in a septal wall separating the first heart chamber from thesecond heart chamber.

Such a method of treating a human heart by implanting a pacing device inthe heart may optionally include one or more of the following features.The one or more pacing electrodes of the first flange portion may beadjacent the septal wall. The pacing device may also include one or morepacing electrodes exposed on an inward-facing surface of the secondflange portion that faces the first flange portion. The one or morepacing electrodes of the second flange portion may be adjacent theseptal wall. The first heart chamber and the second heart chamber may beeach atria. The first heart chamber and the second heart chamber may beeach ventricles. The pacing device may be collapsible for deploymentusing a delivery sheath and may be self-expandable upon emergence fromthe delivery sheath.

In another aspect, a method of treating a human heart by implanting apacing device in the heart is provided. The pacing device includes afirst flange portion; a second flange portion; a central portionextending between and connecting the first flange portion and the secondflange portion; and one or more pacing electrodes exposed on aninward-facing surface of the first flange portion that faces the secondflange portion. The first flange portion is disposed in a first heartchamber, the second flange portion is disposed in a pericardial cavity,and the central portion is disposed in a myocardium separating the firstheart chamber from the pericardial cavity.

Such a method of treating a human heart may optionally include one ormore of the following features. The pacing device may also include oneor more pacing electrodes exposed on an inward-facing surface of thesecond flange portion that faces the first flange portion. The one ormore pacing electrodes of the first flange portion and of the secondflange portion may be adjacent the myocardium.

In another aspect, a method of treating a human heart by implanting apacing device in the heart is provided. The pacing device includes: afirst flange portion; a second flange portion; a central portionextending between and connecting the first flange portion and the secondflange portion; and one or more pacing electrodes exposed on aninward-facing surface of the first flange portion that faces the secondflange portion. The first flange portion is disposed in an atrialappendage of the heart, the second flange portion is disposed in aventricular outflow tract of the heart, and the central portion isdisposed in a myocardium separating the appendage from the outflowtract.

Such a method of treating the human heart may optionally include one ormore of the following features. The atrial appendage may be a rightatrial appendage and the ventricular outflow tract may be a rightventricular outflow tract. The atrial appendage may be a left atrialappendage and the ventricular outflow tract may be a left ventricularoutflow tract.

Particular embodiments of the subject matter described in this documentcan be implemented to realize one or more of the following advantages.First, the designs provided herein facilitate stable, reliable anchoringof electrodes in relation to the myocardium. Second, in some cases thedevices provided herein function as a dual-purpose device, i.e., as anoccluder and as an electrode/coil carrying device for pacing and/orresynchronization. Third, in some cases the devices provided hereinfacilitate atrioventricular pacing using a single device implanted in asingle location. Fourth, while placing conventional leads in a thinseptum/membrane has been known to cause defects, the systems and methodsprovided herein create an opening in a controlled manner and then sealsthe opening. Fifth, the devices and methods provided herein facilitatepacing in specific desirable conduction system areas. Sixth, in somecases the devices and methods provided herein allow for painless cardiacdefibrillation. Seventh, in some embodiments mechanical device linkagesare created that can be advantageous for clot prevention duringfibrillation. In some embodiments, various heart conditions can betreated in a minimally invasive fashion using the devices and methodsprovided herein. Such minimally invasive techniques can reduce recoverytimes, patient discomfort, and treatment costs.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention pertains. Pulse generation which causescontraction of the selected chamber is termed “capture.” Althoughmethods and materials similar or equivalent to those described hereincan be used to practice the invention, suitable methods and materialsare described herein. All publications, patent applications, patents,and other references mentioned herein are incorporated by reference intheir entirety. In case of conflict, the present specification,including definitions, will control. In addition, the materials,methods, and examples are illustrative only and not intended to belimiting.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description herein. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of an example cardiac pacing and/orresynchronization electrode-carrying device in accordance with someembodiments provided herein.

FIG. 2 is a cross-sectional view of the cardiac pacing and/orresynchronization electrode-carrying device of FIG. 1.

FIG. 3 is a schematic cross-sectional view of a human heart with examplecardiac pacing and/or resynchronization electrode-carrying devicesimplanted in various areas of the heart.

FIG. 4 is a schematic cross-sectional view of a human heart with anotherexample cardiac pacing and/or resynchronization electrode-carryingdevice implanted in the heart.

FIG. 5 is a schematic cross-sectional view of a human heart with anotherexample cardiac pacing and/or resynchronization electrode-carryingdevice implanted in the heart.

Like reference numbers represent corresponding parts throughout.

DETAILED DESCRIPTION

This document provides devices and methods for artificial cardiac pacingand/or resynchronization. For example, this document provides improvedelectrodes for stimulating and sensing electrical activity of the heart,and provides pacing and resynchronization systems incorporating suchelectrodes. While the devices and methods provided herein are describedprimarily in the context of pacing, it should be understood thatresynchronization can additionally or alternatively be performed in ananalogous manner, and that the scope of this disclosure includes suchsubject matter.

In some embodiments, the devices provided herein are well-suited toproviding specific conduction system pacing, i.e., in specific desirablecardiac conduction system areas. For example, as described furtherbelow, some embodiments provided herein provide pacing in specificdesirable conduction system areas such as, but not limited to the Hisbundle, the penetrating bundle of His, the proximal conduction system,to provide a few examples. For example, in some embodiments the distalend of the cardiac pacing and/or resynchronization electrode-carryingcardiac device can be located in the right ventricular outflow tract andthe device can curve around the crista supraventricularis such that theproximal end of the device is located in the atrium. In some cases, suchan implementation would facilitate specific conduction system captureand sensing in addition to atrial and ventricular pacing.

One skilled in the art will perceive that the devices described hereincan provide multiple treatment modalities using a single device. Forexample, some embodiments of the devices provided herein aredual-purpose devices, i.e., functioning as an occluder device and as anelectrode/coil carrying device for pacing and/or resynchronization. Inone example implementation, some devices described herein can beimplanted in a patent foramen ovale (PFO). In addition toclosing/occluding the PFO, the device can provide pacing and/orresynchronization.

In some embodiments, the devices provided herein are configured to beretrievable. For example, in some embodiments the devices providedherein can be recaptured into the lumen of a catheter/sheath and removedfrom the patient endovascularly. In some embodiments, the devicesprovided herein can be retrieved using a subcutaneous retrievaltechnique.

Referring to FIGS. 1 and 2, an example cardiac pacing and/orresynchronization electrode-carrying cardiac device 100 (hereinafterreferred to as “pacing device 100”) can be adapted for advantageoushuman use in multiple different manners, as described herein. Pacingdevice 100 includes a first flange portion 110, a second flange portion120, and a central connecting portion 130. In some cases, portions 110,120, and 130 are integrally constructed. In some cases, portions 110,120, and 130 are initially constructed separately and then joinedtogether.

Pacing device 100 is configured for deployment in a minimally-invasivemanner. That is, pacing device 100 is diametrically collapsible so thatpacing device 100 can be deployed in vivo from a lumen of a low-profilecatheter/sheath. Pacing device 100 is shown in its expandedconfiguration. That is, in some embodiments pacing device 100 willself-expand to the approximate shape shown when relieved from thediametric constraints of a catheter/sheath. Pacing device 100 may becomeelongated when diametrically collapsed to its low-profile configuration.

In some embodiments, pacing device 100 is made of a framework of one ormore elongate members (e.g., wires, struts, and the like). For example,in some embodiments pacing device 100 is made of one or more metallicwires that are braided or woven and then shape-set into theconfiguration shown. In another example, in some embodiments pacingdevice 100 is made of a cut-tube of material that is then expanded andshape-set into the configuration shown. In some embodiments, a metalsuch as Nitinol or stainless steel is used for the framework of pacingdevice 100. In some embodiments, one or more radiopaque (RO) markers maybe included on various locations of the pacing device 100.

Pacing device 100 is compliant, elastic, and flexible so as to conformto the sometimes irregular topography of the tissue that it may be incontact with. Moreover, pacing device 100 is designed to maintain robusttissue contact in spite of the dynamic tissue topography associated withthe cardiac cycle.

In some embodiments, pacing device 100 include features directed toenhancing migration resistance such as, but not limited to, macro anchorfeatures (e.g., prongs, hooks, barbs, atraumatic probes, spikes, etc.)or micro anchor features (e.g., a grouping of small protrusions, surfacetexturing, etc.). One or more mechanical features such as hooks, rings,lassos, tethers, eyelets, and the like can be included on pacing device100 to facilitate deployment, repositioning, and/or retrieval of pacingdevice 100.

In some embodiments, a covering material may be included on portions ofpacing device 100. Such a covering material may be made of materialsincluding, but not limited to, PTFE, ePTFE, DACRON, and the like. Insome cases, the covering material may enhance the occlusive propertiesof pacing device 100. In some cases, the covering material may betreated to enhance tissue growth, and promote encapsulation andendothelialization of tissue to encourage anatomical closure of a tissueaperture. In some embodiments, the covering can be modified by one ormore chemical or physical processes that enhance certain physicalproperties of the covering. For example, a hydrophilic coating may beapplied to the covering to improve the wettability and echo translucencyof the covering. In some embodiments, the covering may be modified withchemical moieties that promote one or more of endothelial cellattachment, endothelial cell migration, endothelial cell proliferation,and resistance to thrombosis. In some embodiments, the covering may bemodified with covalently attached heparin or impregnated with one ormore drug substances that are released in situ to promote wound healingor reduce tissue inflammation. In some embodiments, the drug may be acorticosteroid, a human growth factor, an anti-mitotic agent, anantithrombotic agent, or dexamethasone sodium phosphate.

Pacing device 100 can include one or more pacing electrodes and/orresynchronization coils. In the depicted example embodiment, firstflange portion 110 includes four electrodes 112, 114, 116, and 118. Asdescribed further below, electrodes 112, 114, 116, and 118 are disposedon the tissue-contacting surface of first flange portion 110 that isinward-facing and that faces second flange portion 120. In someembodiments, electrodes are included only on one portion (either onfirst flange portion 110 or second flange portion 120) of pacing device100. In some embodiments, electrodes are included on both portions (onfirst flange portion 110 and on second flange portion 120) of pacingdevice 100. Any number of electrodes can be included.

It should be understood that any configuration of a wide variety ofpossible electrode/coil configurations can be used for pacing device100, and all such configurations are within the scope of thisdisclosure. For example, in some embodiments pacing device 100 isconfigured as a unipolar pacing device. That is, in some embodiments theone or more electrodes of pacing device 100 are cathode(s) electrode(s),and a remotely implanted pulse generator module acts as an anodeelectrode. In some embodiments, pacing device 100 is configured as abipolar device. That is, in some embodiments one or more electrodes onone portion of the device (either on first flange portion 110 or secondflange portion 120) are cathode(s) and one or more electrodes on theopposite portion of the device are anode(s).

The pulse generation and other control aspects for operating pacingdevice 100 can originate from various devices and by various technicalmanners. Any and all such different iterations are within the scope ofthis disclosure. For example, in some embodiments pacing device 100 isconnected via one or more leads to a remotely implanted pulsegenerator/controller. In some embodiments, pacing device 100 is awireless pacing device. As a wireless pacing device, pacing device 100can utilize active RF technology, passive RF technology, or technologyby which both pacing device 100 and a remote generator/controller cantransmit and receive communications.

In some embodiments, pacing device 100 is fully self-contained. That is,in some embodiments the componentry of a generator/controller can beintegrally contained in pacing device 100. For example, in someembodiments pacing device 100 includes an interior space 132 defined bycentral connecting portion 130 that can house such componentry of agenerator/controller.

In some embodiments, pacing device 100 is configured only for cardiacpacing. In some embodiments, pacing device 100 is configured forperformance of resynchronization only. In some embodiments, pacingdevice 100 is configured for both cardiac pacing and resynchronization.

Referring also to FIG. 3, pacing device 100 can be implanted in a humanheart 10 in a number of different locations, and using a number ofdifferent deployment techniques. Only some of the possible advantageousdeployment locations are illustrated here. Heart 10 includes a rightatrium 12, an atrial septum 13, a left atrium 14, a right ventricle 15,a ventricular septum 16, a left ventricle 17, a right ventricular freewall 18, and a left ventricular free wall 19.

In a first example, pacing device 100 can be implanted in atrial septum13. Accordingly, first flange portion 110 is disposed in right atrium 12and second flange portion 120 is disposed in left atrium 14. The one ormore electrodes 112, 114, 116, and 118 are in contact with atrial septum13. Such an arrangement can provide, in some cases, compact AV nodalstimulation, and/or synchronous atrial stimulation, to provide a coupleof examples.

In some cases, central connecting portion 130 of pacing device 100 isimplanted in an aperture that is created for the purpose of implantingpacing device 100. Alternatively, in some cases pacing device 100 isadvantageously implanted in a previously existing aperture such as a PFOor other type of septal/membrane defect. In such a case, pacing device100 performs the dual-purpose of pacing/resynchronization and occlusion.

In another example, pacing device 100 can be implanted in ventricularseptum 16. Accordingly, first flange portion 110 is disposed in rightventricle 15 and second flange portion 120 is disposed in left ventricle17. The one or more electrodes 112, 114, 116, and 118 are in contactwith ventricular septum 16. Such an arrangement can provide, ventricularstimulation and or resynchronization.

In some cases, in order to obviate or minimize the need for making aseptal puncture, pacing device 100 can be implanted in a Thebesian veinof ventricular septum 16. Such a deployment can be performed, forexample, using a Doppler sensor on a wire to detect the location of aThebesian vein in ventricular septum 16. Thereafter, the wire can beused to penetrate the Thebesian vein and one or more other deploymentdevices can be used over the wire to deploy pacing device 100.

In another example, pacing device 100 can be implanted in rightventricular free wall 18 (or in left ventricular free wall 19).Accordingly, first flange portion 110 is disposed in right ventricle 15and second flange portion 120 is disposed in the pericardial cavity. Theone or more electrodes 112, 114, 116, and 118 are in contact withventricular free wall 18 (on either surface of ventricular free wall 18,i.e., the epicardial surface or the endocardial surface).

In still another example, pacing device 100 can be implanted between anatrial appendage and a ventricular outflow tract. For example, theimplanted arrangement can be either between the right atrial appendageand the right ventricular outflow tract, or between the left atrialappendage and the left ventricular outflow tract. Accordingly, firstflange portion 110 is disposed in right or left atrial appendage andsecond flange portion 120 is disposed in the right or left ventricularoutflow tract, respectively. While these arrangements are notillustrated, one of skill in the art will understand the arrangementsbased on the description. In these arrangements, pacing device 100 willfunction as an atrioventricular pacing and/or resynchronization device.That is, pacing device 100 will provide pacing and/or resynchronizationfor both atrial and ventricular chambers of heart 10.

In yet another example, pacing device 100 can be implanted through theright atrial appendage and into the right ventricular outflow tract.This implementation will provide the capability of atrioventricularpacing without crossing the tricuspid valve. Moreover, the outflow tracttends to produce more synchronous biventricular pacing than other sites.The deployment procedure would involve the trans-catheter device thatfacilitates the entry of a transseptal-like needle via the right atrialappendage into the right outflow tract. Then, a small wire would bepassed from the right outflow tract into the right atrial appendage. Forguidance, an expandable or flat deflectable component with or withoutmagnet aid in the right atrial appendage can be used. Such a devicewould serve to maximize apposition to the right ventricular outflowtract while passing the wire and deploying the device. This techniquefor deploying pacing device 100 into the right ventricular outflow tractwould decrease the potential for bleeding into the pericardial space.

Pacing device 100 can be implanted using various minimally invasive orsurgical techniques. For example, in some cases pacing device 100 can beplaced using an endocardial approach via vascular access. In such acase, femoral veins, subclavian veins, internal jugular veins, and thelike, can be used for transvenous access. In some cases, an epicardialapproach can be used to place pacing device 100. In such a case,subxiphoid or intercostal accesses can be used for example. In somecases, pacing device 100 can be implanted using an open chest surgicaltechnique. Moreover, in some cases a guidewire, along with a punctureneedle, is inserted into the vasculature, internally snared, and thenpulled out of the patient so that both ends of the guidewire arecontrolled using a counter-traction technique. In such a case, pacingdevice 100 can be then implanted using either an inside out technique,or an outside in technique.

In some embodiments, pacing device 100 can also be equipped with variousother features that can extend the functionality provided be pacingdevice 100. For example, in some embodiments pacing device 100 caninclude one or more pressure sensors for detecting pressures on firstflange portion 110 and/or second flange portion 120. In some such cases,the measured pressure(s) can be used as inputs of an algorithm of thecontrol circuitry of pacing device 100 to modify the pacing scheme(e.g., adjust which electrode(s) 112, 114, 116, and/or 118 are beingused for stimulation, adjust pulse timing, and the like).

In some embodiments, pacing device 100 can also be equipped withpiezoelectric crystals and/or tissue Doppler devices to sense myocardialperformance. Signals from such devices can be used for aspects such as,but not limited to, early myocardial infarction (MI) detection, and/orto change the pacing vector to improve myocardial performance.

In some embodiments, pacing device 100 can also be equipped with one ormore electromagnets. In addition, in some embodiments electromagnets canbe positioned in one or more other locations in heart 10 that are spacedapart from pacing device 100. Then, the electromagnets can be activatedand/or deactivated to induce myocardial movement. Such movement can helpprevent thrombus formation, for example, during fibrillation.

Referring to FIG. 4, another example cardiac pacing and/orresynchronization electrode-carrying cardiac device 200 (hereinafterreferred to as “pacing device 200”) can be adapted for advantageoushuman use in multiple different manners, as described herein. Pacingdevice 200 includes a first flange portion 210, a second flange portion220, a third flange portion 230, a transvalvular connecting portion 234,and a transseptal connecting portion 240. Transvalvular connectingportion 234 extends between first flange portion 210 and third flangeportion 230. Transseptal connecting portion 240 extends between firstflange portion 210 and second flange portion 220.

Pacing device 200 is a tri-flanged device. In some cases (as depicted),first flange portion 210 is disposed in right atrium 12 and is incontact with the atrial septum 13. Second flange portion 220 is disposedin left atrium 14 and is in contact with the atrial septum 13. Thirdportion 230 is disposed in right ventricle 15 and is in contact withventricular septum 16. Other arrangements are also envisioned. Forexample, first flange portion 210 can be disposed in left atrium 14,second flange portion 220 can be disposed in right atrium 12, and thirdportion 230 can be disposed in left ventricle 17.

In the depicted arrangement, transvalvular connecting portion 234extends through the tricuspid valve, generally adjacent to an anteriortricuspid valve annulus 20. In some cases, transvalvular connectingportion 234 is configured to extend through a commissure of the valve'sleaflets. Pacing device 200 is configured to not contribute to valvularregurgitation.

The use of pacing device 200 facilitates specific His bundle pacingeither on the membranous septum 16 or in the distal AV node transitionalzone with or without being able to sense and pace atrial and ventricularmyocardium at the same time.

In some cases, portions 210, 220, 230, and 240 are integrallyconstructed. In some cases, one or more of the portions 210, 220, 230,and 240 are initially constructed separately and then joined together.

Pacing device 200 is configured for deployment in a minimally-invasivemanner. That is, pacing device 200 is diametrically collapsible so thatpacing device 200 can be deployed in vivo from a lumen of a low-profilecatheter/sheath. Pacing device 200 is shown in its expandedconfiguration. That is, in some embodiments pacing device 200 willself-expand to the approximate shape shown when relieved from thediametric constraints of a catheter/sheath. Pacing device 200 may becomeelongated when diametrically collapsed to its low-profile configuration.

In some embodiments, pacing device 200 is made of a framework of one ormore elongate members (e.g., wires, struts, and the like). For example,in some embodiments pacing device 200 is made of one or more metallicwires that are braided or woven and then shape-set into theconfiguration shown. In another example, in some embodiments pacingdevice 200 is made of a cut-tube of material that is then expanded andshape-set into the configuration shown. In some embodiments, a metalsuch as Nitinol or stainless steel is used for the framework of pacingdevice 200. In some embodiments, one or more RO markers may be includedon various locations of the pacing device 200.

Pacing device 200 is compliant, elastic, and flexible so as to conformto the sometimes irregular topography of the tissue that it may be incontact with. Moreover, pacing device 200 is designed to maintain robusttissue contact in spite of the dynamic tissue topography associated withthe cardiac cycle.

In some embodiments, pacing device 200 include features directed toenhancing migration resistance such as, but not limited to, macro anchorfeatures (e.g., prongs, hooks, barbs, atraumatic probes, spikes, etc.)or micro anchor features (e.g., a grouping of small protrusions, surfacetexturing, etc.). One or more mechanical features such as hooks, rings,lassos, tethers, eyelets, and the like can be included on pacing device200 to facilitate deployment, repositioning, and/or retrieval of pacingdevice 200.

In some embodiments, pacing device 200 is configured only for cardiacpacing. In some embodiments, pacing device 200 is configured forperformance of resynchronization only. In some embodiments, pacingdevice 200 is configured for both cardiac pacing and resynchronization.

The flange portions 210, 220, and 230 of pacing device 200 can includeone or more pacing electrodes and/or resynchronization coils likedescribed above in reference to pacing device 100. In some embodiments,electrodes are included only on one or two flange portions 210, 220,and/or 230 of pacing device 200. In some embodiments, electrodes areincluded on all portions 210, 220, and 230 of pacing device 200. Anynumber of electrodes can be included.

It should be understood that any configuration of a wide variety ofpossible electrode/coil configurations can be used for pacing device200, and all such configurations are within the scope of thisdisclosure. For example, in some embodiments pacing device 200 isconfigured as a unipolar pacing device. That is, in some embodiments theone or more electrodes of pacing device 200 are cathode(s) electrode(s),and a remotely implanted pulse generator module acts as an anodeelectrode. In some embodiments, pacing device 200 is configured as abipolar device. That is, in some embodiments one or more electrodes onone portion of the device (either on first flange portion 210, secondflange portion 220, and/or third flange portion 230) are cathode(s) andone or more electrodes on the opposite portion of the device areanode(s).

The pulse generation and other control aspects for operating pacingdevice 200 can originate from various devices and by various technicalmanners. Any and all such different iterations are within the scope ofthis disclosure. For example, in some embodiments pacing device 200 isconnected via one or more leads to a remotely implanted pulsegenerator/controller. In some embodiments, pacing device 200 is awireless pacing device. As a wireless pacing device, pacing device 200can utilize active RF technology, passive RF technology, or technologyby which both pacing device 200 and a remote generator/controller cantransmit and receive communications.

In some embodiments, pacing device 200 is fully self-contained. That is,in some embodiments the componentry of a generator/controller can beintegrally contained in pacing device 200. For example, in someembodiments pacing device 200 includes an interior space defined bytransseptal connecting portion 240 that can house such componentry of agenerator/controller.

In some embodiments, pacing device 200 is configured only for cardiacpacing. In some embodiments, pacing device 200 is configured forperformance of resynchronization only. In some embodiments, pacingdevice 200 is configured for both cardiac pacing and resynchronization.

Referring to FIG. 5, another example cardiac pacing and/orresynchronization electrode-carrying cardiac device 300 (hereinafterreferred to as “pacing device 300”) can be adapted for advantageoushuman use in multiple different manners, as described herein. Pacingdevice 300 includes a first flange portion 310, a second flange portion320, and a transvalvular connecting portion 330. Transvalvularconnecting portion 330 extends between first flange portion 310 andsecond flange portion 320.

In the depicted arrangement, transvalvular connecting portion 330extends through the tricuspid valve, generally adjacent to an anteriortricuspid valve annulus 20. Pacing device can also be used for themitral valve. In some cases, transvalvular connecting portion 330 isconfigured to extend through a commissure of the valve's leaflets.Pacing device 300 can be placed anywhere on a valve annulus, and canalso be placed in other locations such as, but not limited to,epicardially on the left atrial appendage or the right atrial appendage.Pacing device 300 is configured to not substantially contribute tovalvular regurgitation.

In some embodiments, first flange portion 310 includes electrodes (orcoils) that are on the atrial myocardium near the high septal annulus.In some embodiments, second flange portion 320 includes one or moreelectrodes (or coils) on the ventricular side of the annulus in asimilar location. Pacing device 300 leverages the fact that the annulusand the fibrous skeleton of the heart are smaller in circumference anddiameter than the neighboring atrial and ventricular myocardium allowingpacing device 300 to be deployable. This type of leadless devicedeployment and stability can be used in other regions as well.

Pacing device 300 is configured for deployment in a minimally-invasivemanner. That is, pacing device 300 is diametrically collapsible so thatpacing device 300 can be deployed in vivo from a lumen of a low-profilecatheter/sheath. Pacing device 300 is shown in its expandedconfiguration. That is, in some embodiments pacing device 300 willself-expand to the approximate shape shown when relieved from thediametric constraints of a catheter/sheath. Pacing device 300 may becomeelongated when diametrically collapsed to its low-profile configuration.

In some embodiments, pacing device 300 is made of a framework of one ormore elongate members (e.g., wires, struts, and the like). For example,in some embodiments pacing device 300 is made of one or more metallicwires that are braided or woven and then shape-set into theconfiguration shown. In another example, in some embodiments pacingdevice 300 is made of a cut-tube of material that is then expanded andshape-set into the configuration shown. In some embodiments, a metalsuch as Nitinol or stainless steel is used for the framework of pacingdevice 300. In some embodiments, one or more RO markers may be includedon various locations of the pacing device 300.

Pacing device 300 is compliant, elastic, and flexible so as to conformto the sometimes irregular topography of the tissue that it may be incontact with. Moreover, pacing device 300 is designed to maintain robusttissue contact in spite of the dynamic tissue topography associated withthe cardiac cycle.

In some embodiments, pacing device 300 include features directed toenhancing migration resistance such as, but not limited to, macro anchorfeatures (e.g., prongs, hooks, barbs, atraumatic probes, spikes, etc.)or micro anchor features (e.g., a grouping of small protrusions, surfacetexturing, etc.). One or more mechanical features such as hooks, rings,lassos, tethers, eyelets, and the like can be included on pacing device300 to facilitate deployment, repositioning, and/or retrieval of pacingdevice 300.

In some embodiments, pacing device 300 is configured only for cardiacpacing. In some embodiments, pacing device 300 is configured forperformance of resynchronization only. In some embodiments, pacingdevice 300 is configured for both cardiac pacing and resynchronization.

The flange portions 310 and 320 of pacing device 300 can include one ormore pacing electrodes and/or resynchronization coils like describedabove in reference to pacing device 100. In some embodiments, electrodesare included only on one flange portion 310 or 320 of pacing device 300.In some embodiments, electrodes are included both portions 310 and 320of pacing device 300. Any number of electrodes can be included.

It should be understood that any configuration of a wide variety ofpossible electrode/coil configurations can be used for pacing device300, and all such configurations are within the scope of thisdisclosure. For example, in some embodiments pacing device 300 isconfigured as a unipolar pacing device. That is, in some embodiments theone or more electrodes of pacing device 300 are cathode(s) electrode(s),and a remotely implanted pulse generator module acts as an anodeelectrode. In some embodiments, pacing device 300 is configured as abipolar device. That is, in some embodiments one or more electrodes onone portion of the device (either on first flange portion 310 and/orsecond flange portion 320) are cathode(s) and one or more electrodes onthe opposite portion of the device are anode(s).

The pulse generation and other control aspects for operating pacingdevice 300 can originate from various devices and by various technicalmanners. Any and all such different iterations are within the scope ofthis disclosure. For example, in some embodiments pacing device 300 isconnected via one or more leads to a remotely implanted pulsegenerator/controller. In some embodiments, pacing device 300 is awireless pacing device. As a wireless pacing device, pacing device 300can utilize active RF technology, passive RF technology, or technologyby which both pacing device 300 and a remote generator/controller cantransmit and receive communications.

In some embodiments, pacing device 300 is fully self-contained. That is,in some embodiments the componentry of a generator/controller can beintegrally contained in pacing device 300. For example, in someembodiments pacing device 300 includes an interior space defined bytransvalvular connecting portion 330 that can house such componentry ofa generator/controller.

In some embodiments, pacing device 300 is configured only for cardiacpacing. In some embodiments, pacing device 300 is configured forperformance of resynchronization only. In some embodiments, pacingdevice 300 is configured for both cardiac pacing and resynchronization.

It is also envisioned that a pacing device with the two-partcharacteristics of pacing device 300 can be used to approximate cardiacstructures for pacing and/or resynchronization purposes. For example, inone such exemplary implementation a first portion of the clamshell-likestructure can be secured to/against the left atrial appendage and thesecond portion can be either kept free or secured to/against the rightatrial appendage. In this implementation, no cardiac structures arepunctured, while the implementation helps facilitate multisite pacing ofstructure(s) not easy to otherwise pace.

It should be understood that one or more features from a particularembodiment described herein can be combined with one or more featuresfrom one or more other embodiments described herein. Hence, all suchpossible hybrid designs are envisioned within the scope of thisdisclosure.

Another design iteration that can be incorporated in any of the pacingdevice embodiments described herein is to make the devices of twomaterials (e.g., could be two types of nitinol). The first type ofmaterial (which, for example, could be near a septal puncture siteand/or distally on the circumflex) would be a softer material that isless traumatic, and would not have the electrode components which wouldnecessarily add stiffness. Such a soft material would serve as somethingas a buttress and hemostatic mechanism while the stiffer portion thatincludes electrode components will allow for sensing in the pacingand/or defibrillation while maintaining stability and contact. Anotherdesign variation can include deployable buttresses or “skirts” that canbe activated by an external magnet or an internal deployment device thatwould be separate from what is left behind, in case bleeding or lack ofstability is noted after implant.

While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anyinvention or of what may be claimed, but rather as descriptions offeatures that may be specific to particular embodiments of particularinventions. Certain features that are described in this specification inthe context of separate embodiments can also be implemented incombination in a single embodiment. Conversely, various features thatare described in the context of a single embodiment can also beimplemented in multiple embodiments separately or in any suitablesubcombination. Moreover, although features may be described herein asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination may be directed to asubcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multitasking and parallel processingmay be advantageous. Moreover, the separation of various system modulesand components in the embodiments described herein should not beunderstood as requiring such separation in all embodiments, and itshould be understood that the described program components and systemscan generally be integrated together in a single product or packagedinto multiple products.

Particular embodiments of the subject matter have been described. Otherembodiments are within the scope of the following claims. For example,the actions recited in the claims can be performed in a different orderand still achieve desirable results. As one example, the processesdepicted in the accompanying figures do not necessarily require theparticular order shown, or sequential order, to achieve desirableresults. In certain implementations, multitasking and parallelprocessing may be advantageous.

What is claimed is:
 1. A cardiac pacing device comprising: a firstflange portion; a second flange portion; a third flange portion; atransseptal connecting portion extending between and connecting thefirst flange portion and the second flange portion; a transvalvularconnecting portion extending between and connecting the first flangeportion and the third flange portion; one or more pacing electrodesexposed on an inward-facing surface of the first flange portion thatfaces the second flange portion: and controller circuitry housed in thecardiac pacing device, wherein the cardiac pacing device is a fullyself-contained and leadless pacing device, wherein the first, second,and third flange portions are arranged relative to each other such thatthe first and second flanges are positionable in atria on opposite sidesof an atrial septum of a heart while the third flange portion ispositioned in a ventricle of the heart.
 2. The cardiac pacing device ofclaim 1, further comprising one or more pacing electrodes exposed on aninward-facing surface of the second flange portion that faces the firstflange portion.
 3. The cardiac pacing device of claim 1, furthercomprising one or more resynchronization coils exposed on theinward-facing surface of the first flange portion that faces the secondflange portion.
 4. The cardiac pacing device of claim 1, furthercomprising: a wireless receiver configured for wireless communicationwith a controller separated from the cardiac pacing device, wherein thecontroller wirelessly communicates to the cardiac pacing device tocontrol the cardiac pacing device.
 5. The cardiac pacing device of claim1, wherein the controller circuitry is housed at least partially in thetransseptal connecting portion of the cardiac pacing device.
 6. Thecardiac pacing device of claim 1, further comprising: one or morepressure sensors coupled to the cardiac pacing device and configured fordetecting a fluid pressure adjacent the cardiac pacing device.
 7. Thecardiac pacing device of claim 6, wherein the one or more pressuresensors includes: (i) a first pressure sensor coupled to and positionedon the first flange portion and (ii) a second pressure sensor coupled toand positioned on the second flange portion, wherein the first pressuresensor is configured to detect a fluid pressure in a first heart chamberand wherein the second pressure sensor is configured to detect a fluidpressure in a second heart chamber that differs from the first heartchamber.
 8. A cardiac pacing device comprising: a first flange portion;a second flange portion; a transvalvular connecting portion extendingbetween and connecting the first flange portion and the second flangeportion; and one or more pacing electrodes exposed on an inward-facingsurface of the first flange portion that faces the second flangeportion, wherein each of the first and second flange portions comprise aframework of one or more shape-set elongate metallic members, whereinthe first and second flange portions are arranged relative to each othersuch that the first and second flanges are positionable on oppositesides of an annulus of a heart valve while the transvalvular connectingportion extends through a leaflet commissure of the heart valve.
 9. Thecardiac pacing device of claim 8, wherein frameworks of the first andsecond flange portions each comprise woven metallic wires.
 10. Thecardiac pacing device of claim 8, wherein frameworks of the first andsecond flange portions each comprise cut-tube constructions of Nitinol.11. The cardiac pacing device of claim 8, further comprising a coveringmaterial on portions of the cardiac pacing device.
 12. The cardiacpacing device of claim 8, further comprising controller circuitry housedin the cardiac pacing device such that the cardiac pacing device is afully self-contained and leadless pacing device.